Graham Reynolds, vice president and general manager, Global Biologics, West Pharmaceutical Services, Inc., spoke to Contract Pharma about the latest trends in injectable drug packaging and delivery, specifically in the diabetes market, as well as how biosimilars are impacting drug makers’ packaging and delivery strategies.

Contract Pharma: What are some of the latest trends in injectable drug packaging and delivery, specifically in the diabetes market?

Graham Reynolds: Injectable insulin has been the base treatment for diabetes a long time and prefilled syringes, cartridges and insulin pens remain key to administration. The pen will continue to grow because of increasing prevalence and detection of diabetes. However, new treatments, such as GLP-1 agonists, show even more promise. Studies of these medications have shown potential to impact weight loss, which could help to address obesity, a common comorbidity of diabetes. GLP-1 agonists are administered either in combination with insulin, or separately in a weekly dosing.

With most diabetes medications taking injectable form, drug makers are increasingly exploring the use of prefillable self-injection systems for their administration. Self-injection systems can give patients freedom to self-manage their disease outside of the doctor’s office. However, with this approach comes new considerations around risk mitigation.

Regulatory bodies around the world are asking drug and packaging manufacturers to ensure consistent quality throughout a drug product’s lifecycle in order to minimize risks to the patient and the drug. In this new era of treatment, the adoption of Quality by Design (QbD) principles in drug development and manufacturing is a way to put patients first. QbD delivers an improved, data-driven output, providing manufacturers with superior product and process understanding that minimizes risk, emphasizes patient-critical quality requirements and enhances drug effectiveness.

The adoption of QbD principles in the design and manufacturing of packaging components provides a drug package that is optimized to meet these same stringent needs. New component offerings designed using QbD principles, such as West’s NovaPure components for prefillable syringe systems, address growing need for high-quality packaging solutions.

Building quality into the development and manufacturing process from the start helps ensure that high quality standards are met through commercialization and allows the industry to reach its ultimate goal: delivering safe, effective medications to patients.

CP: How is the rise of biosimilars impacting drug makers’ packaging and delivery strategies?

GR: Many injectable biosimilars are sensitive, creating potential for interaction with containers and packaging components. Some areas of concern are potential delamination of glass vials, interaction with silicone oil and tungsten from glass syringes, and extractables and leachables from elastomeric closures. All these issues may compromise a drug’s quality and potentially put patients at risk. Such nuances are leading drug, packaging and delivery system manufacturers to think differently about containment and delivery to better ensure drug efficacy and patient safety.

One area where we are seeing continued interest is polymer containers. High-quality polymer systems, such as the Daikyo Crystal Zenith cyclic olefin polymer, when combined with high-quality coated elastomer components, add value to biosimilars through enhanced cleanliness and decreased interaction with the drug product. These polymers can be also molded into a variety of shapes and designed to enable larger fill volumes and tighter dimensional tolerances.

Additionally, innovators faced with the looming threat from biosimilar competition, are increasingly seeking new approaches to drug delivery to provide lifecycle management and competitive differentiation. Innovations may take the form of enhanced drug delivery systems, which may offer options to enhance the overall patient experience through a more patient-centric delivery system, or improved dosage regimens (e.g., moving from a weekly dose to a monthly dose). Companies may also seek to enhance the overall patient experience through differentiated patient services or support. One option to provide an enhanced system, with less-frequent dosing, is West’ SmartDose platform which was designed to easily integrate into a patient’s lifestyle. The single-use, electronic wearable injector adheres to the patient’s body, usually on the abdomen. The platform incorporates a Daikyo Crystal Zenith container combined with FluroTec coated elastomeric components. It was designed for simplicity and patient comfort, while facilitating the delivery of innovative drug products.

Choosing the correct packaging and delivery system can not only make self-administration easier, but it can also encourage brand preference among patients and practitioners. Early interaction between the innovator or biosimilar company and a delivery system provider can help mitigate risk, deliver a high-quality product and foster patient affinity.

CP: Any updates on West for 2017 and beyond?

GR: This year at INTERPHEX and DCAT Week ’17, we’re excited to participate in a number of educational sessions and showcase several offerings that demonstrate West’s ability to meet both the current and future needs of our customers as they work to innovate drug administration in the management of diseases for patients globally. Throughout 2017 and beyond, we are continuing to help our pharmaceutical and biotechnology partners around the world address increasingly complex challenges around ensuring the quality, usability and production efficiency of a medicine across its lifecycle.

Our top priority is delivering quality products that meet the exact product specifications and quality standards customers require and expect, while continuing to provide innovative, patient-centric delivery systems. This focus on quality includes excellence in manufacturing, scientific and technical expertise and management. At the manufacturing level, this means producing clean, sterile, high-quality components to minimize disruptions to the supply chain and bringing safe, effective drug products to market—and to the patient—quickly and efficiently.